MAUDE Adverse Event Report: MEDTRONIC, INC. VALLEYLAB SM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	VSMP15
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a breast procedure, the devices were involved in a brief open flame at the distal tip of the electrode.The procedure was momentarily paused due to the sentinel event involving the open flame.The technique used involved a metal pointed clamping instrument clamped onto tissue, with the electrode placed touching the jaws of the instrument and activated, causing the electrical circuit to move through the jaws to the target tissue.After the electrode was removed from the instrument, a flame briefly appeared at the distal tip and then went away quickly.A new generator was retrieved and the case resumed after replacing the electrode and opening an older smoke evac pencil from another manufacturer.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant products: vlft10gen, vlft10gen ft series energy platformx1 (serial#:unknown), e1455, e1455 the edge ent/ima electrode x50 (lot#:unknown) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a breast procedure, the devices were involved in a brief open flame at the distal tip of the electrode.The procedure was momentarily paused due to the sentinel event involving the open flame which was extinguished by stopped pressing the activating energy button.The technique used involved a metal pointed clamping instrument clamped onto tissue, with the electrode placed touching the jaws of the instrument and activated, causing the electrical circuit to move through the jaws to the target tissue.After the electrode was removed from the instrument, a flame briefly appeared at the distal tip and then went away quickly.There was no operating room fire.A new generator was retrieved, and the case resumed after replacing the electrode and opening an older smoke evac pencil from another manufacturer.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VALLEYLAB SM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24751610
• Report Number: 2182208-2026-15402
• Device Sequence Number: 21368605
• Product Code: GEI
• UDI-Device Identifier: 10884521836365
• UDI-Public: (01)10884521836365(17)290630(10)2503211X
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K240572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VSMP15
• Device Catalogue Number: VSMP15
• Device Lot Number: 2503211X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Female